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Rhythm Pharmaceuticals
NEWS

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…
March 20, 2026

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NEWS

Novartis to Acquire Pikavation Therapeutics from Synnovation for ~$3B

Shots: Novartis has entered into a definitive agreement with Synnovation to acquire Pikavation Therapeutics (Synnovation’s subsidiary) & its portfolio of PI3Kα inhibitor programs, incl. SNV4818, a P-I/II asset for HR+/HER2- metastatic breast cancer & other solid tumors As per the deal, Synnovation will receive $2B upfront, & ~$1B in development, regulatory, & commercial milestones, representing…
March 20, 2026

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NEWS

Embecta to Acquire Owen Mumford for ~£150M

Shots: Embecta has entered into a definitive agreement to acquire Owen Mumford, expanding drug-delivery capabilities & strengthening global presence in the chronic care market As per the deal, Embecta will acquire Owen Mumford for ~£150M (~$199.9M), incl. £100M (~$133.2M) upfront & up to £50M (~$66.6M) in sales-based milestones tied to Aidaptus, with closing expected in…
March 20, 2026

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NEWS

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus Trial met its 1EP & key 2EPs showing…
March 20, 2026

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NEWS

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Shots: The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions &…
March 19, 2026

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Pfizer New
NEWS

Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Pfizer has reported P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi in 599 pts with HRR gene-mutated mHSPC Trial met its 1EP, showing improved rPFS with a hazard ratio surpassing the pre-specified target of 0.63, as most pts remained progression-free; consistent benefit was observed across tumors with both…
March 19, 2026

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