PharmaShots’ Key Highlights of Fourth Quarter 2024
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The Fourth quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Roche's acquisition of Poseida Therapeutics for ~$1.5B
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This quarter also showcased multiple clinical trial results including Pfizer's P-III Study Data of Talzenna + Xtandi to treat mCRPC
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Our team at PharmaShots has summarized and compiled the insights of Q4'2024
Date: Oct 1, 2024
Product: Enhertu
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The sBLA for Enhertu has been accepted for priority review by the US FDA to treat HER2-low or ultralow metastatic breast cancer in patients who have received at least 1 endocrine therapy, with the decision expected during Q1’25
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The submission was based on P-III (DESTINY-Breast06) study assessing Enhertu (5.4mg/kg) vs investigator’s choice of CT (capecitabine, paclitaxel or nab-paclitaxel) to treat HR+/HER2-low or ultralow advanced or metastatic breast cancer
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Study demonstrated reduced risk of disease progression or death by 37% with mPFS of 13.2mos. vs 8.1mos. in the overall population. Similar results were seen in HER2-low & ultralow patients, with mPFS of 13.2mos. vs 8.1mos. & 13.2mos. vs 8.3mos., respectively
Date: Oct 3, 2024
Product: Calquence
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The US FDA has accepted & granted priority review to sNDA of Calquence for treatment-naïve adults with mantle cell lymphoma. The decision is expected during Q1’25
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Submission was based on P-III (ECHO) study assessing the safety & efficacy of Calquence + bendamustine & rituximab (SoC) vs SoC to treat MCL adults (n=635, over 65yrs.). Data was featured at EHA 2024
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The study showed a 27% reduction in the disease progression or death risk with an mPFS of 66.4mos. vs 49.6mos. and an immature OS with favorable trends (assessment continues). In the pre-specified analysis, carried out at the time of pandemic censoring COVID-19-related deaths, showed improved PFS of 36% across both arms & a favorable OS trend towards the regimen
Recordati to Acquire Sanofi’s Enjaymo, Enhancing its Rare Diseases Portfolio
Date: Oct 4, 2024
Product: Enjaymo
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Recordati has signed an agreement with Sanofi to secure worldwide rights of Enjaymo (sutimlimab), developed for the treatment of cold agglutinin disease (CAD)
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As per the agreement, Sanofi will get $825M upfront and additional ~$250M commercial milestones if net sales achieved certain thresholds at or above the top end of peak year sales expectations. The deal is anticipated to conclude by the YE’24, pending regulatory approvals
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Enjaymo (IV) is a humanized mAb approved to treat hemolysis in adults with CAD across major markets. It works by targeting C1s in the classical complement pathway to inhibit complement cascade activation & C1 activated hemolysis, preventing abnormal destruction of healthy RBCs
Date: Oct 8, 2024
Product: N/A
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Caldera Medical has acquired UVision 360 and added LUMINELLE hysteroscopy & cystoscopy systems, strengthening its minimally invasive hysteroscopy portfolio for diagnosing & treating polyps, fibroids & intrauterine pathology
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Caldera's Benesta line together with the LUMINELLE system will bolster gynecologic surgeons' capabilities, enhancing results for intrauterine treatments like polypectomies, biopsies & fibroid resections in both office and surgical settings
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The LUMINELLE system offers high-resolution optics and ease of use, providing a cost-effective, minimally invasive option for diagnostic and therapeutic hysteroscopy, enhancing procedural precision and patient recovery time
Pfizer Reports the Data from P-III (TALAPRO-2) Study of Talzenna Plus Xtandi for Treating mCRPC
Date: Oct 10, 2024
Product: Talzenna + Xtandi
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Pfizer has reported topline results from the P-III (TALAPRO-2) trial assessing Talzenna (0.5mg/day) + Xtandi (160mg/day) vs PBO to treat mCRPC patients (N=1,035) being divided in two arms of all-comers (n=805, 169 with HRR mutations) & HRR mutation +ve (n=399, 169 from arm 1 & 230 in arm 2)
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Study depicted a significantly improved OS and an improved rPFS that maintained during the final analysis in both the arms. These results confirm the earlier findings published in The Lancet
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Safety profile aligned with the previously established results of each drug. Data will be highlighted at the future conferences and will be shared with regulatory authorities worldwide, seeking approval for the same
Johnson & Johnson Completes the Acquisition of V-Wave
Date: Oct 11, 2024
Product: N/A
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Johnson & Johnson has successfully completed the acquisition V-Wave with aim to establish leadership in the cardiovascular segment to tackle heart failure
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Under US GAAP, this transaction will be treated as an asset acquisition, leading in-process R&D charge of about $600M in Q4’24. J&J projects a diluted adjusted EPS impact of roughly $0.24 in 2024 and ~$0.06 in 2025. Full-year financial outlook will be presented on Oct 15, 2024
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Now V-wave will to be part of J&J’s Medtech cardiovascular segment, where Ventura Interatrial Shunt an innovative implantable device, which holds great potential for heart failure with reduced ejection fraction (HFrEF) patients
Lundbeck to Acquire Longboard Pharmaceuticals, Strengthening its Neuroscience Portfolio
Date: Oct 15, 2024
Product: N/A
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Lundbeck has agreed to acquire Longboard under a strategic agreement to strengthen its neuro-rare disease portfolio
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As per the agreement, Lundbeck will launch a tender offer to acquire all outstanding Longboard shares for $60 per share in cash, valuing the deal at $2.6B in equity, out of which $2.5B is net of cash (~DKK 17B). It is expected to conclude in Q4’24
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The acquisition will add bexicaserin (5-HT2C agonist), being developed to treat seizures in Dravet syndrome, Lennox-Gastaut syndrome & other rare epilepsies, to Lundbeck’s portfolio. It is in a global P-III (DEEp SEA) trial as part of the DEEp program (DEEp SEA, DEEp OCEAN & DEEp OLE) that will enroll ~480 subjects across 80 sites globally, with its launch planned in Q4’28
Ocuphire Pharma to Acquire Opus Genetics
Date: Oct 23, 2024
Product: Phentolamine Ophthalmic Solution, APX3330 & OPGx-LCA5
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Ocuphire will acquire all the stocks of Opus to form a combined entity, ‘Opus Genetics’, focusing on gene therapies for IRDs
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Acquisition adds AAV-based gene therapies for IRDs, Phentolamine Ophthalmic Solution 0.75% [in P-III (VEGA-3) for presbyopia & (LYNX-2) for dim light vision disturbances post-surgery], APX3330 (to be developed under an alliance for non-proliferative diabetic retinopathy) & OPGx-LCA5 (in P-I/II for LCA5 with 1st pediatric patient enrollment expected in Q1’25 & initial data in Q3’25)
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Cash runway has been extended into 2026 during which data from pediatric patients in OPGx-LCA5’s P-I/II & initial patients in OPGx-BEST1’s P-I/II are expected. The P-III (LYNX-2 & VEGA-3) trials are enrolling actively, with top-line data expected in Q1 & H1’25, respectively
GSK to Acquire Chimagen Biosciences’ CMG1A46, Expanding its Immunology Pipeline
Date: Oct 23, 2024
Product: CMG1A46
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GSK has reported an agreement with Chimagen Biosciences to acquire the CMG1A46. GSK aims to develop & commercialize CMG1A46, focusing on B cell-driven autoimmune diseases such as SLE & LN, to expand into other related autoimmune disorders
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As per the agreement, GSK will pay $300M upfront for full global rights to CMG1A46. Chimagen may also receive up to $550M in milestone payments based on the successful development & commercialization. The agreement is subject to standard conditions, including required regulatory approvals under the Hart-Scott-Rodino Act in the US
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CMG1A46 is a dual-targeted TCE that focuses on CD19&20. It is currently in a P-I study for leukemia and lymphoma in the US & China. GSK intends to launch a P-I study for lupus in 2025
AbbVie to Acquire Aliada Therapeutics for ~$1.4B
Date: Oct 28, 2024
Product: ALIA-1758
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AbbVie has agreed to acquire Aliada Therapeutics, bolstering its focus on Alzheimer's disease and neuroscience portfolio
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As per the agreement, AbbVie will buy all the outstanding shares of Aliada for $1.4B in cash, with the deal anticipated to close in Q4’24, pending regulatory and customary approvals
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The acquisition adds Aliada's lead asset, ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in P-I trials for AD, and its Modular Delivery (MODEL) platform, enabling precision CNS drug delivery using BBB-crossing technology targeting TfR and CD98 receptors in brain endothelial cells to AbbVie’s portfolio
Date: Nov 4, 2024
Product: JADE-001, JADE-002 & JADE-003
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The reverse merger will form a combined entity that will trade as Jade on Nasdaq under the ticker ‘JBIO’, with the premerger Aerovate stockholders getting ~1.6% & premerger Jade stockholders owning ~98.4% of it. Aerovate will not fund the combined entity & will pay ~$65M to its premerger stockholders before closing (expected in H1’25)
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In support of the merger, Jade gained commitments for an oversubscribed private investment expected to yield ~$300M from healthcare investors that will fund the combined entity’s operations through 2027
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The combined entity will advance JADE-001 (anti-APRIL mAb) into clinical PoC for IgAN during H2’25, with initial readout in H1’26. Jade has also begun preclinical studies of JADE-002 & JADE-003
Boston Scientific Reports the Acquisition of Cortex
Date: Nov 6, 2024
Product: N/A
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Boston Scientific has agreed to acquire Cortex (an Ajax Health company), strengthening its electrophysiology portfolio for treating complex atrial fibrillation. Financial terms were undisclosed; closing is anticipated during H1’25, pending customary conditions
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The acquisition adds Cortex’ FDA-approved OptiMap System to Boston’s portfolio. Cortex has concluded the system’s FLOW-AF study, showing 51% improved AF freedom 1yr. post-ablation vs conventional therapy, plus has begun another global RESOLVE-AF for detecting extra-pulmonary vein sources in 300 patients
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The OptiMap System detects active AF sources through a basket catheter & algorithm, enabling physicians create personalized ablation strategies
Date: Nov 7, 2024
Product: N/A
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GHO Capital Partners and Ampersand Capital Partners have agreed to acquire Avid Bioservices in an all-cash transaction for an enterprise value of ~$1.1B
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As per the agreement, GHO and Ampersand will acquire all the Avid’s outstanding shares for $12.50 per share in cash, which accounts for 13.8% premium to Avid's last closing price
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The deal is expected to conclude during Q1’25. Upon closing, Avid will be operated privately under its current name and brand
Aditum Bio and Leads Biolabs Launch Oblenio Bio to Advance LBL-051 for Autoimmune Indications
Date: Nov 7, 2024
Product: LBL-051
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Aditum Bio & Leads Biolabs have launched Oblenio Bio to develop LBL-051 targeting autoimmune indications, with Aditum funding the venture and both companies working to advance it into clinical evaluations
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Leads Biolabs gives Oblenio Bio an exclusive option for developing, manufacturing & commercializing LBL-051 globally, with Leads entitled to receive up to $35M in upfront & near-term payments, $579M in milestones, sales-based royalties and an equity stake
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LBL-051, developed on the LeadsBody Platform, is a tri-specific T-cell engager targeting CD19, BCMA & CD3. It is designed to improve safety & effectiveness by precisely adjusting the potency of each domain
Kalaris Therapeutics Reverse Merges with AlloVir to Advance Therapies Focusing on Retinal Disease
Date: Nov 11, 2024
Product: TH103
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Allovir will acquire 100% outstanding shares of Kalaris, forming a combined entity that will trade as Kalaris on Nasdaq under the ticker, ‘KLRS’, with its focus on developing therapies targeting retinal diseases. Deal is anticipated to conclude in Q1’25
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On completion, the pre-Merger AlloVir stockholders will own ~25.05% & pre-Merger Kalaris stockholders will own ~74.95% of the combined entity. The merged entity expects to have $100M in cash to cover expenses & capital needs until Q4’26
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The entity will advance TH103 for which the recruitment in P-I study to assess safety, PK/PD, MTD & preliminary anti-VEGF effects on fluid and visual acuity in treatment-naïve nAMD patients has begun by Kalaris, with initial readout planned in Q3’25
Date: Nov 12, 2024
Product: ATA-200
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The US FDA has cleared the IND application of ATA-200 to initiate the P-Ib/IIb clinical evaluation for limb-girdle muscular dystrophy type 2C/R5 (LGMD2C/R5). ATA-200 also received the FDA’s ODD for the same
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The P-Ib dose escalation trial will assess the safety, PD, efficacy & immunogenicity of ATA-200 among children with the recruitment set to begin in Q4’24; trial is funded by The Dion Foundation for Children with Rare Diseases. It has also received regulatory clearance in France & Italy
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ATA-200 is a one-time gene therapy for LGMD2C/R5, that transfers a normal gene for producing γ-sarcoglycan. It showed tolerability and symptom correction in non-clinical studies
Date: Nov 14, 2024
Product: BNT327
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The acquisition will enhance BioNTech's capabilities in development, manufacturing & commercialization of next-gen BsAbs & novel therapies in oncology; will expand its reach in China
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Biotheus will get $800M upfront & $150M milestones, with the closing anticipated in Q1’25. It follows a 2023 licensing deal granting BioNTech global rights to BNT327/PM8002 outside Greater China
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BioNTech secures full rights to Biotheus' pipeline, in-house bispecific ADC capability, biologics manufacturing facility & global rights of BNT327 (targets PD-L1 & VEGF-A). BNT327’s potential will be explored with BioNTech’s ADCs; its registrational & combination therapy trials are planned in 2024 & 2025. A P-I/II study of BNT327 + BNT325/DB-1305 for solid tumors began in Jun 2024
Novartis Reports the Acquisition of Kate Therapeutics for ~$1.1B
Date: Nov 22, 2024
Product: KT-809
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Novartis has agreed to acquire Kate Therapeutics, strengthening its portfolio comprising of gene therapies for neuromuscular diseases
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As per the agreement, Kate Therapeutics’ shareholders are eligible to receive ~$1.1B, including undisclosed upfront and payments on reaching a certain milestone
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The acquisition adds Kate’s preclinical KT-430 for X-linked myotubular myopathy, KT-809 for DMD, 4 discovery candidates (facioscapulohumeral dystrophy, muscular dystrophy, cardiomyopathy & myotonic dystrophy type-1) as well as two platforms Deliver and Cargo to develop AAV-based gene therapies, to Novartis’ portfolio
Date: Nov 22, 2024
Product: Nubeqa
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The US FDA has accepted for review the sNDA of Nubeqa plus androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC)
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The sNDA was supported by P-III (ARANOTE) study assessing the safety & efficacy of Nubeqa (600mg, BID) in addition to ADT vs PBO for treating mHSPC patients (n=669), with the results highlighted at ESMO 2024 and published in The Journal of Clinical Oncology
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Results demonstrated significant reduction in the progression or death risk with the combination of Nubeqa & ADT without new safety concerns
Roche to Acquire Poseida Therapeutics for ~$1.5B
Date: Nov 26, 2024
Product: P-BCMA-ALLO1, P-CD19CD20-ALLO1, P-MUC1C-ALLO1
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Roche will acquire Poseida for $9/share in cash, strengthening its CAR-T therapy portfolio, with the deal closing in Q1’25
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Roche will also pay a total of $4/share non-tradeable CVR as milestones ($2 for pivotal trial of P-BCMA-ALLO1 by Dec 2028, $1 for a pivotal trial of P-CD19CD20-ALLO1 or P-BCMACD19-ALLO1 in autoimmune indication by Dec 2034 & $1 for P-BCMA-ALLO1’s sale by Dec 2031), valuing the deal at ~$1.5B
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Acquisition adds Poseida’s P-BCMA-ALLO1 (in P-I for MM), P-CD19CD20-ALLO1 (in P-I for B-cell malignancies, with FDA INDs for multiple sclerosis & SLE), another allogeneic dual CAR-T therapy for hematologic malignancy, P-MUC1C-ALLO1 (in P-I for solid tumors), GMP manufacturing capabilities plus genomic pre-clinical medicines & related tech
Silo Pharma and Kymanox Join Forces for SP-26 Ketamine Implant Device Targeting Pain Management
Date: Dec 2, 2024
Product: SP-26
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Silo Pharma has collaborated with Kymanox (SC insertaion device) to develop for SP-26 targeting fibromyalgia and chronic pain. Kymanox also serves as Silo’s regulatory partner for SPC-15, a prophylactic treatment for stress-induced disorders like PTSD
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Kymanox will lead SP-26's proof-of-concept design, prototype development, and feasibility testing to find optimal tissue insertion depth. Its preclinical study focused on SP-26 meeting FDA safety standards for potential at-home use
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Silo’s SP-26 is a ketamine-based dissolvable implant for chronic pain and fibromyalgia, designed for controlled dosage and time release
PTC Therapeutics Join Forces with Novartis to Develop PTC518 for Treating Huntington's Disease
Date: Dec 3, 2024
Product: PTC518
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PTC & Novartis have partnered to develop PTC518 Huntington's disease program, incl. related molecules, with the latter handling the development, manufacturing & commercialization post P-II (PIVOT-HD) study completion (planned in H1’25)
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PTC will receive $1B upfront, up to $1.9B development, regulatory & sales milestones plus double-digit tiered royalties on ex-US sales, with a US profit split of 40% (PTC) & 60% (Novartis). Closing is planned in Q1'25
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PTC518 is developed from PTC's splicing platform. Interim results from its P-II showed dose-dependent reductions in blood and cerebrospinal fluid (CSF) mutant Huntingtin protein and early signs of clinical benefit at 12mos., with a favorable safety & tolerability
Date: Dec 3, 2024
Product: ATX101
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The US FDA has granted BTD to ATX101 for treating adults with post-surgical pain following total knee replacement surgery
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Designation was based on dose-ranging P-II exploratory study of ATX101 vs bupivacaine (SoC) in 112 subjects, showing sustained pain relief for up to 2wks., decreased opioid use & associated side effects plus improved functional activities & satisfaction for up to 60 days. A registrational P-IIb trial in 200 individuals is planned in 2025 across the US
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ATX101 is an investigational formulation of bupivacaine (intracellular sodium ion channel blocker) and a biopolymer indicated for relieving pain post total knee arthroplasty (TKA)
Date: Dec 3, 2024
Product: D-2570
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InventisBio has reported the results from P-II study assessing the safety & efficacy of D-2570’s (oral selective TYK2 kinase inhibitor) three dose levels vs PBO to treat patients (n=161) with moderate to severe plaque psoriasis
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Study depicted PASI 75 in ≥85% vs 12.5% across all the dose levels, with PASI 100 (complete skin clearance) in 50% vs 2.5%, PASI 90 in 77.5% vs 5.0% & sPGA 0/1 in 87.5% vs 20% across high dose level at wk.12
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D-2570 was well-tolerated, with mostly mild to moderate AEs and no new safety signals; safety aligned with other TYK2 inhibitors. Full data will be highlighted at future conferences
Date: Dec 4, 2024
Product: Zepbound
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Eli Lilly reported topline data from P-IIIb (SURMOUNT-5) study assessing safety & efficacy of Zepbound (10 or 15mg) vs Wegovy (1.7or 2.4mg) in obese adults (n=751) with hypertension, dyslipidemia, obstructive sleep apnea (OSA) or cardiovascular disease & not having diabetes
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Study depicted 47% greater weight loss than Wegovy, with an average loss of 20.2% vs 13.7% at 72wks. and 31.6% vs 16.1% of Zepbound users achieved ≥25% weight loss (2EP). Both drugs showed similar safety profiles, with mostly mild to moderate gastrointestinal AEs
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Lilly will further analyze results from SURMOUNT-5 trial and will publish in a journal and conference during 2025
Date: Dec 9, 2024
Product: Calquence + venetoclax
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The P-III (AMPLIFY) study assessed Calquence + venetoclax with/without obinutuzumab vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL patients without del(17p) or TP53 mutation
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Trial (median follow-up of 41mos.) depicted a 58% (with obinutuzumab) & 35% (without obinutuzumab) reduction in the disease progression or death risk; mPFS was not achieved (both arms) vs 47.6mos. OS data favored Calquence + venetoclax, but the data was immature so, its assessment is underway (2EP)
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Furthermore, 36mos. PFS rates were 83.1% & 76.5% vs 66.5% & ORRs were 92.7% & 92.8% vs 75.2% with & without obinutuzumab, respectively
Date: Dec 11, 2024
Product: Vanflyta
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The first patient has been dosed with Vanflyta + standard CT in P-III (QuANTUM-Wild) study, built on P-II (QUIWI) trial assessing Vanflyta with standard intensive CT and as subsequent maintenance monotx.
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The trial will involve newly diagnosed FLT3-ITD-ve AML patients (n= ~700; 18-70yrs.) divided across 3 arms, Vanflyta (arm A) or PBO (arm B) + cytarabine & anthracycline induction, then cytarabine consolidation CT, followed by maintenance therapy for up to 3yrs. in the US, EU, Asia & Australia
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Arm C will explore Vanflyta with induction & consolidation CT followed by PBO maintenance for exploratory analysis. The 1EP is OS & 2EPs are EFS, CR duration & rate, CR with MRD negativity, relapse-free survival, PK & safety
AbbVie to Bolster its Immunology Pipeline Through the Acquisition of Nimble Therapeutics
Date: Dec 12, 2024
Product: NA
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AbbVie has signed a definitive agreement to acquire Nimble Therapeutics for $200M upfront, plus interim funding and a potential milestone payment
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The acquisition adds Nimble’s preclinical oral peptide IL23R inhibitor for psoriasis and IBD plus a pipeline of oral peptide candidates for autoimmune diseases to AbbVie’s portfolio
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In addition, AbbVie will also get Nimble's peptide synthesis, screening & optimization platform for rapid peptide discovery and optimization across various targets
Immedica Pharma Reports the Acquisition of Marinus Pharmaceuticals for $151M
Date: Dec 31, 2024
Product: Ztalmy
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Immedica Pharma has agreed to acquire all the outstanding shares of Marinus Pharmaceuticals for $0.55 per share, making it an aggregate of $151M. The deal is anticipated to close in Q1’25
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The acquisition will expedite Immedica's entry into the North America by adding Marinus’ portfolio (incl. a commercial-stage asset in the US) and an experienced commercial team
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The acquisition further enhances Immedica’s rare disease portfolio with Ztalmy (ganaxolone), an oral suspension, CV, neuroactive steroid GABA-A receptor +ve modulator approved for CDD-related seizures in patients (≥2yrs.) by the FDA, EC, MHRA & NMPA, with potential for more global approvals
Reliance Industries Reports the Acquisition of Karkinos Healthcare for ~$43.88M
Date: Dec 31, 2024
Product: NA
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Reliance Industries, through its subsidiary Reliance Strategic Business Ventures (RSBVL), has acquired Karkinos Healthcare for ~$43.88M (INR 375 Cr)
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The acquisition aims to expand Reliance's health services portfolio, enhancing its presence in the healthcare sector
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Karkinos is a tech-based healthcare platform that specializes in early cancer detection, diagnosis, treatment & management. It has collaborated with 60 hospitals (as of Dec 2023) to offer these services plus will set up a 150-bed cancer hospital in Imphal, Manipur
Related Post: PharmaShots' Key Highlights of Third Quarter 2024
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
