Officials of Akebia Therapeutics Inc. talked with investors about what might be ahead for vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease, which draw a complete response letter (CRL) from the FDA. Akebia and partner Otsuka Pharmaceutical Co. Ltd. will meet with the agency to get more detail on safety concerns noted in the CRL. Shares of Akebia (NASDAQ:AKBA) were trading midday at 71 cents, down 12 cents, or 14%.

Clovis’ Rubraca improves PFS in phase III study

Positive top-line data from the phase III monotherapy arm of Clovis Oncology Inc.’s PAPR inhibitor Rubraca as a first-line maintenance treatment of ovarian cancer hit the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared to placebo. The median PFS was 20.2 months for Rubraca compared to 9.2 months for placebo in the intent-to-treat group. Patients with HRD-negative and BRCA-mutant tumors also saw a PFS benefit. Clovis said it plans to submit an sNDA for a label expansion sometime in the second quarter of 2022. The Boulder, Colo.-based company’s stock (NASDAQ:CLVS) more than doubled at midday on the news, with shares trading 54% higher.

Inflarx MAb misses mark in study of severe COVID-19 patients

A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but did not show statistical significance on the prespecified primary endpoint. Despite the outcome, "we believe that data from the study suggest that vilobelimab treatment resulted in a robust signal for survival improvement when compared to placebo, particularly in those patients from Western Europe and those with higher baseline severity," said Inflarx CEO and founder Niels Riedemann. Company shares (NASDAQ:IFRX) fell 14.4% to $2.05 by midday.

Recbio raises HK$765M in Hong Kong IPO, shares rise 1.8% on first trading day

Jiangsu Recbio Technology Co. Ltd. raised HK$765 million (US$97.7 million) in a Hong Kong stock exchange IPO on March 31. Shares of the vaccine maker (HKEX:2179) opened at HK$25 per share and rose 1.8% to close at HK25.25 apiece. The Jiangsu, China-based company plans to use about half the proceeds, or HK$317.9 million, to support development and commercialization of its HPV vaccines, including its lead asset, a phase III recombinant HPV nine-valent vaccine REC-603, a spokesperson told BioWorld. The company also plans to set up an HPV manufacturing facility in Taizhou, China.

Antibody firm Remegen raises $410M in Shanghai IPO, but stock tumbles

Less than a year after winning approval in China for the first domestically developed antibody-drug conjugate (ADC), Remegen Co. Ltd. raised ¥2.6 billion (US$410 million) and picked up a listing on the Shanghai STAR market to support further work on its monoclonal antibodies and ADCs. Its stock opened at ¥46 per share on March 31, though it plunged 14.92% to end the day at ¥40.84. Yantai, China-based Remegen plans to use ¥1.6 billion of the proceeds for the commercialization of its products, including telitacicept (RC-18), along with and antibodies and ADC drug disitamab vedotin (RC-48).

Neurological stocks boosted by Voyager deal, Caplyta growth, Ztalmy approval

After hitting a low in late February, BioWorld’s Neurological Diseases Index (BNDI) is rebounding, although it is still down by 8.9% this year, following the same path of the broader markets. The highs and lows among the 17 components were influenced by everything from a billion-dollar capsid deal and a seizure drug approval to workforce reductions and amyotrophic lateral sclerosis disappointments. The Nasdaq Biotechnology Index is down 10.4%, while the Dow Jones Industrial Average is down 2.9%, but all three indexes are showing an improvement over last month.

New shortage threatens Rx supply chain

Throughout the COVID-19 pandemic, biopharma companies have had to deal with shortages resulting from global supply chain issues. Early on, it was a shortage of the glass needed for vaccine vials and then critical drug and vaccine ingredients. Now drug companies are facing a much more basic shortage – the raw materials needed to manufacture the “board” and pressure-sensitive label stock required for packaging their prescription products. “Without these packaging components, prescription drugs cannot be distributed,” several U.S. lawmakers informed President Joe Biden this week. They called the emerging threat a “potentially dangerous situation” that could delay the manufacturing and distribution of COVID-19 therapies, as well as other prescription drugs.

Securities fraud class actions still a source of cost for life science companies

Publicly traded companies in the life sciences face a number of sources of litigation, including lawsuits over alleged securities fraud, and a new report by Dechert LLP highlights a diminishing number of such lawsuits across the U.S. economy. However, the proportion of such lawsuits directed at drug and device makers has not diminished, making clear that companies in the life sciences must tread carefully when disclosing information such as the status of products in development for fear that a perceived misrepresentation could spark expensive and time-consuming litigation.

US SEC proposal aims at SPAC space

The U.S. SEC is proposing rules that would close off some of the advantages of going public via a special purpose acquisition company, or SPAC. The rules and amendments would enhance disclosure and investor protection in SPAC IPOs, bringing them in line with the requirements for traditional IPOs. The proposal also would impact business combination transactions involving private companies and shell companies, including SPACs. BioWorld reported nearly 30 mergers of biopharma companies with SPACs last year and more than $4 billion raised through SPAC IPOs targeting life sciences firms. Heading into this year, about 60 SPACs were working on mergers with life sciences companies.

Also in the news

Abeona, Accutar, Airway, Akston, Amylyx, Anixa, Autolus, Brii, Catalyst, Cerevance, Cidara, Clovis, Crinetics, Cstone, Cytodyn, Design, Develco, Eloxx, Everest, Evolus, Fauna, Genprex, Glaxosmithkline, Hasten, Immuneid, Incyclix, Inflarx, JW, Marinus, Mission, Myeloid, Nordic, Novartis, Novavax, Nrx, Numab, Oncolytics, Ono, Outlook, Portage, Prime Medicine, PTC, Scisparc, Sorrento, Stealth, Sumitomo Dainippon, Surface, Tilt, Tevard, Trevena, V-Bio, Vertex, Xortx