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Ever­est climbs clos­er to Covid-19 boost­er mar­ket; A French up­start snags funds to find drugs

Everest Medicines said its Covid-19 messenger RNA partner passed a mid-stage test investigating its vaccine against Pfizer and BioNTech’s Comirnaty.

Providence Therapeutics’ PTX-COVID19-B was non-inferior to the Big Pharma’s shot in a Phase II trial comparing the vaccines in 18- to 64-year-olds in Canada and South Africa, Everest disclosed Wednesday. The shot was tested as a two-jab intramuscular injection.

Pfiz­er nabs eq­ui­ty stake in Swiss biotech work­ing on celi­ac ther­a­py; Verona gets more cash af­ter COPD win

Pfizer is investing in new treatments for celiac disease.

The Big Pharma shelled out $35 million in equity for Anokion, a Swiss biotech shooting for a celiac therapy. Anokion intends to use the money to fund Phase II studies for the candidate, known as KAN-101 and acquired in a 2019 buyout of Astellas-backed Kanyos Bio. Pfizer also gets a seat each on Anokion’s board of directors and scientific advisory board.

Bio­Marin heads to FDA with he­mo­phil­ia A gene ther­a­py; Covid-fo­cused biotech signs a small SPAC deal

BioMarin’s gene therapy is getting a shot at the FDA as the agency accepted the BLA, the biotech said Wednesday night.

With a decision date of March 31, 2023, an approval would come two and a half years after the regulator originally rejected the AAV gene therapy, which the biotech netted conditional approval for in the EU in late August.

BioMarin is attempting to become the first gene therapy maker in the US to secure an approval for severe hemophilia A, which is characterized by spontaneous episodes of bleeding.

Mod­er­na gets Au­to­lus tar­get­ing tech via li­cens­ing deal; Atai re­ports PhI da­ta for kratom-based ther­a­py

A year after Autolus Therapeutics got itself a partner in Moderna via a licensing deal, Moderna is exercising its option to acquire the biotech’s proprietary binders.

The London-based Autolus revealed the option Wednesday morning, saying that the mRNA giant has exercised its option to in-license for an undisclosed I/O target. The original agreement between the two companies was reached back in August 2021, which gave Moderna the option to license Autolus’ tech for up to four immune-oncology targets.

Rigel steps back from sN­DA fil­ing plans for bleed­ing dis­or­der drug; NMD gives first look in­to myas­the­nia gravis pro­gram

In June, Rigel reported a Phase III fail for its only approved drug, fostamatinib, in warm autoimmune hemolytic anemia, or wAIHA for short, an autoimmune disease in which healthy red blood cells are destroyed prematurely. At the time, Rigel attributed the failure to placebo arm patients in eastern European countries who had higher rates of durable response than those in the active cohort.

But after hearing back from the FDA after it submitted its reanalysis, Rigel no longer plans to submit an sNDA for wAIHA, it announced Monday afternoon.

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

No­vo Nordisk touts an­oth­er once-week­ly in­sulin win; Mere­o's board bat­tle heats up again

Novo Nordisk has completed the posting of topline results across its six Phase IIIa clinical trials in the ONWARDS program, rounding out a full-fledged effort to bring another diabetes treatment to market.

In ONWARDS 5, once-weekly insulin icodec was found to be non-inferior to once-daily basal insulin in reducing HbA1c, the Danish Big Pharma reported Monday. With that, the 52-week open-label trial met its primary endpoint at the end of the study.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Gami­da Cell prices its fol­low-on pub­lic of­fer­ing at $20M; Rally­bio touts Phase Ib da­ta for mon­o­clon­al an­ti­body

While Gamida Cell is still charging its way toward approval for its therapies with new CEO Abigail Jenkins in place, it’s looking to garner a little more cash.

The company announced on Wednesday that it will be offering up over 12 million shares and expecting proceeds of an estimated $20 million. The offer is expected to close on Sept. 30. According to Gamida Cell, it plans to use the cash to help with the potential launch of its omidubicel therapy if it gets approval. Omidubicel has a PDUFA date set for Jan. 30, 2023.

Seagen and Zai Lab ink part­ner­ship on Tiv­dak ex­pan­sion in­to Chi­na and sur­round­ing ar­eas; NC biotech snaps up seed fund­ing

Zai Lab has signed on to commercialize Seagen and Genmab’s Tivdak — an ADC for recurrent or metastatic cervical cancer in patients in which chemotherapy isn’t working — in mainland China, Hong Kong, Macau and Taiwan.

Seagen will get $30 million upfront, along with downstream milestone payments and tiered royalties. But the company will be splitting all earnings from the Zai Lab agreement 50:50 with Genmab.