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Bridge­Bio to raise $150M; FDA ac­cepts Ion­is' an­ti­sense drug NDA

After BridgeBio publicly disclosed a Phase II win Monday morning, it’s now wanting $150 million.

The biotech said Monday afternoon that it started an underwritten public offering for $150 million worth of shares, allowing underwriters to buy an additional $22.5 million in shares.

An SEC filing from the biotech says the funds are intended to push forward clinical and preclinical development — helping to pay for research activities and working capital. The filing also says BridgeBio “may also use a portion of the net proceeds to invest in or acquire businesses or technologies that we believe are complementary to our own.”

Or­chard lines up mon­ey for pro­posed Lib­meldy ex­pan­sion; Har­bour touts PhI­II

Gene therapy maker Orchard Therapeutics is extending its cash runway into 2025 with new financing agreements to bankroll its path to regulatory approval.

The London and Boston biotech said it could garner $188 million via a securities purchase agreement and a private placement of warrants. Backers include RA Capital, Deep Track Capital, Cowen Healthcare, Woodline Partners and Zentree Investments.

Orchard eyes US clearance of OTL-200, a gene therapy candidate for metachromatic leukodystrophy, after cutting back on other programs last year. The treatment is approved in the EU and other European regions as Libmeldy and brought in $18.8 million last year, Orchard said Monday.

Sum­mit clos­es $500M raise, de­spite low­er mar­ket cap; Rev­o­lu­tion rais­es $300M in stock sale

Bob Duggan’s Summit Therapeutics has completed its $500 million raise — even though its market cap is short of that figure.

Summit, which as of Thursday evening had a valuation of roughly $431 million, sold 476.2 million shares of its stock at $1.05 apiece to bring in the $500 million. The raise comes a few months after Duggan and co-CEO Maky Zanganeh loaned the company $520 million to finance a deal with China’s Akeso Therapeutics.

Val­ne­va re­ports more da­ta on Covid-19 vac­cine; Clin­Choice buys a CRO

Valneva presented updates on its Covid-19 vaccine, the first to get the full marketing green light in Europe, but the French biotech stopped manufacturing of it last year because of reduced order volume in the EU.

The company said it has extended the vaccine’s shelf life by three months, from 18 to 21 months. It also said the European Medicines Agency’s committee gave a positive opinion for using the vaccine, VLA2001, as a booster dose in adults 18 to 50 years old.

Am­i­cus eyes Pompe ap­proval; Atea ends Dengue work; 2sev­en­ty, Tra­vere line up of­fer­ings

Amicus Therapeutics began March with word that the FDA has scheduled a pre-approval inspection of its potential treatment for Pompe disease. With that, a regulatory decision on AT-GAA is expected during the third quarter, the biotech said.

Amicus said last October the FDA wasn’t able to do the required inspection of its manufacturing partner, WuXi Biologics in China, during the review timeframe because of “restrictions on travel related” to the pandemic. AT-GAA consists of biologic cipaglucosidase alfa and miglustat, a stabilizer of the biologic. The approval request includes both a BLA and NDA.

Chi­nook de­lays topline kid­ney con­di­tion da­ta; Elu­minex ropes in $40M+ in a Se­ries B

Chinook’s readout of its Phase III ALIGN trial of atrasentan, a potential treatment for chronic kidney diseases, could be delayed by about three months, the company said in an SEC filing. The trial is looking at atrasentan in patients with immunoglobulin A nephropathy (IgAN), a condition that can cause kidney disease.

The company said the FDA recommended that it add 12 weeks to an interim analysis of patients’ urine protein levels or proteinuria. That would push back the proteinuria data to the fourth quarter of this year. The company said it’s planning to meet with the agency to discuss the recommendation. — Katherine Lewin

Eye­Point and Rally­bio shake hands on col­lab­o­ra­tion; Sh­iono­gi ex­pects bil­lions for Covid an­tivi­ral pill — re­port

EyePoint Pharmaceuticals and Rallybio will be entering into a partnership.

The deal will look at the delivery of Rallybio’s C5 inhibitor using EyePoint’s tech for intraocular drug delivery, dubbed Durasert. The research will focus on geographic atrophy, an advanced form of macular degeneration that can eventually lead to vision loss.

Both companies also intend to expand upon the collaboration following the initial research work. However, no financial details have been given yet. In a release, Rallybio CEO Stephen Uden said that the use of C5 inhibitors has already shown “great promise.” While Jay Duker, president and COO of EyePoint, said that the collaboration hopes to use the technology to provide a more “desirable option” for patients — as the current therapy is injected every one to two months.

Olatec gets $40M to put an­ti-in­flam­ma­to­ry in late-stage tri­al; En­liv­en goes pub­lic, rais­es $165M

A US and Dutch biotech closed its $40 million Series A to bankroll more studies of its oral anti-inflammatory drug.

Olatec Therapeutics said the financing will fund a late-stage clinical trial of its drug, dapansutrile, an NLRP3 inhibitor. Novartis, Roche and Novo Nordisk have all caught wind of the NLRP3 space, with the latter joining in via a deal with Ventus Therapeutics in NASH and other cardio metabolic diseases.

Pfiz­er, Bay­er lay off staff in Cal­i­for­nia; Mod­er­na signs gene edit­ing deal with David Hal­lal biotech

As the layoff trend continues hitting the manufacturing and wider biotech sectors, two more big names have given details of its West Coast layoffs.

German drug manufacturer Bayer is laying off employees at a facility in Berkeley, CA. According to a WARN report submitted to the state of California’s Employee Development Department, it stated that 55 employees will be getting the ax, with the date for that layoff happening in late March.

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Im­mu­ni­ty­Bio, Coda­genix and Eu­Men­tis raise funds, while a biotech SPAC dis­solves

While ImmunityBio is involved in arbitration with Sorrento Therapeutics, which filed for bankruptcy this week to protect from the potential capital burden, the California biotech is pulling together $50 million.

The direct offering could expand up to another $60 million if the undisclosed “multiple institutional investors” exercise the full options on warrants, ImmunityBio said Wednesday morning. The stock $IBRX slipped about 6% after the opening bell.