Financings

Centogene BV filed to sell 4 million common shares on Nasdaq for between $14 and $16 in an IPO expected to raise $60 million at the midpoint.

Disc Medicine Inc. completed a $50 million series A.

Kira Biotech Pty Ltd. raised AU$20 million (US$13.72 million) in series A funding.

Nuvation Bio Inc. closed $275 million in an oversubscribed series A financing.

Oyster Point Pharma Inc. priced an IPO of 5 million shares at $16 each for gross proceeds of about $80 million.

Pinteon Therapeutics Inc. completed a $17 million series A.

Rapt Therapeutics Inc. priced its IPO of 3 million shares at $12 each for proceeds of $36 million.

Rznomics Inc. recently secured ₩12 billion (US$10 million) in a series A investment.

Tmunity Therapeutics Inc. closed a $75 million series B.

Vivo Capital announced the final closing of Vivo Capital Fund IX LP at $1.43 billion.

Y-mabs Therapeutics Inc. priced a public offering of 4.5 million shares at $28 per share, with expectations of raising up to $125 million.

Deals

Beam Therapeutics Inc. signed a collaboration and license agreement with newly formed Prime Medicine Inc. to research and develop a gene editing technology.

Bristol-Myers Squibb Co. extended the expiration date from Oct. 31 to Nov. 4 of its offer to exchange Celgene Corp. notes for up to $19.85 billion.

Cheplapharm Arzneimittel GmbH will pay $178 million up front to Astrazeneca plc for the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia.

Dicerna Pharmaceuticals Inc. inked a collaboration and licensing agreement with Roche Holding AG to develop chronic hepatitis B virus treatment, collecting $200 million up front, with $1.47 billion more possible in development, regulatory and commercial milestone payments.

Gilead Sciences Inc. and Glympse Bio Inc. inked a collaboration in nonalcoholic steatohepatitis clinical development.

Pandion Therapeutics Inc. inked a deal with Astellas Pharma Inc. for $45 million in up-front money and potentially more than $750 million in milestones to develop locally acting immunomodulators for autoimmune diseases of the pancreas.

Pascal Biosciences Inc. and Y-Biologics Inc. plan to discover and develop bispecific antibodies to treat leukemia.

Ziopharm Oncology Inc. and MD Anderson Cancer Center started a new R&D agreement to use nonviral gene transfer to express and evaluate neoantigen-specific T-cell receptors in T cells.

…And More

Agile Therapeutics Inc.’s contraceptive patch, Twirla, won a 14-1 adcom vote in favor of recommending approval, despite negative briefing documents from FDA reviewers.

Amag Pharmaceuticals Inc.’s Makena was voted down 9-7, with members of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee recommending the preterm birth drug be removed from the market.

Aradigm Corp. withdrew its MAA for inhaled antibiotic Linhaliq after learning the EMA’s Committee for Medicinal Products for Human Use was likely to adopt a negative opinion.

Biogen Inc. and Alkermes plc won FDA approval of Vumerity (diroximel fumarate) in multiple sclerosis.

Blueprint Medicines Corp. said the FDA intends to split the proposed indications for avapritinib into two separate NDAs: one for PDGFRA exon 18 mutant gastroesophageal stromal tumors (GIST) regardless of prior therapy, and one for fourth-line GIST.

Cyclerion Therapeutics Inc.’s shares fell nearly 80% after two phase II misses with oral sGC stimulator praliciguat.

Cystic Fibrosis Foundation, of Bethesda, Md., launched Path to a Cure to support cystic fibrosis drug discovery and development with a commitment of $500 million in funding for potential collaborators.

Iveric Bio Inc.’s stock jumped 83% on positive phase IIb data for Zimura in dry age-related macular degeneration.

Medicines360 said the FDA approved a supplemental NDA for contraceptive Liletta (levonorgestrel-releasing intrauterine system) to extend duration of use for up to six years.

Novartis AG said the FDA placed a partial hold on trials for intrathecal administration of gene therapy AVXS-101 in spinal muscular atrophy type 2 based on findings from a small preclinical study in animals showing dorsal root ganglia mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss.

Takeda Pharmaceutical Co. Ltd. reported positive phase III data of its oral suspension of the steroid budesonide in eosinophilic esophagitis.

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