Biotech re­ceives award from DOD; Reg­u­la­tors ac­cept Ap­pili Ther­a­peu­tic­s' NDA

Eu­Men­tis Ther­a­peu­tics, a Boston-based biotech, has been hand­ed an award from the US De­part­ment of De­fense.

The $3 mil­lion award will be used by Eu­Men­tis to work on a small mol­e­cule for trau­mat­ic brain in­jury that aims to tar­get the N-methyl-D-as­par­tate re­cep­tor. Specif­i­cal­ly, the biotech will study three an­tag­o­nists to eval­u­ate TBI in an an­i­mal study this year. That study will be done in col­lab­o­ra­tion with a pro­fes­sor at the Uni­ver­si­ty of Penn­syl­va­nia.

Af­ter the pre­clin­i­cal study fin­ish­es, Eu­Men­tis will plan to ad­vance the can­di­date is se­lect­ed in­to a Phase I tri­al next year. So far, the com­pa­ny has net­ted over $11 mil­lion in fund­ing from the pri­vate sec­tor and gov­ern­ment.

“Cur­rent­ly there are no ap­proved ther­a­peu­tics for trau­mat­ic brain in­jury, which im­pact hun­dreds of thou­sands of Amer­i­cans an­nu­al­ly and leads to sig­nif­i­cant dis­abil­i­ty and death. The De­part­ment of De­fense rec­og­nizes the need for new ther­a­peu­tic ap­proach­es for this ur­gent pub­lic health con­cern, and we are thrilled to re­ceive their sup­port in this com­pet­i­tive area,” said Eu­Men­tis CEO Mark Tep­per in a re­lease.

FDA ac­cepts the NDA For Pen­ny Stock’s can­di­date

Cana­di­an biotech Ap­pili Ther­a­peu­tics will have a date US reg­u­la­tors lat­er this year.

On Wednes­day, the pen­ny stock an­nounced the FDA ac­cept­ed an NDA for a pro­gram called ATI-1501. The drug is a liq­uid oral form of the an­tibi­ot­ic metron­ida­zole, which had been li­censed to Sap­tal­is Phar­ma­ceu­ti­cals. The de­ci­sion date is Sept 23.

The an­tibi­ot­ic it­self is al­ready used to treat bac­te­r­i­al in­fec­tions, but the cur­rent form, ac­cord­ing to Ap­pili’s re­lease, had a bit­ter taste and cur­rent dosage forms are hard for some pa­tients to swal­low. Ap­pili’s for­mu­la­tion is de­signed to be more of a con­ve­nient op­tion for pa­tients need­ing the an­tibi­ot­ic.

“Ap­pili is work­ing with Sap­tal­is on sup­port­ing the re­view process and re­spond­ing to ques­tions posed by the FDA. Ap­proval of ATI-1501 will pro­vide a con­ve­nient treat­ment op­tion for those suf­fer­ing dev­as­tat­ing in­fec­tions that are un­able to take the cur­rent metron­ida­zole tablet treat­ment,” said Ap­pili pres­i­dent and CEO Don Cil­la in a re­lease.

Ap­pili cur­rent­ly finds its share price $APLIF well in­to the pen­ny stock zone and trad­ing at 38 cents per share as of Wednes­day morn­ing.

BPG­Bio ac­quires all as­sets of a Boston-based biotech

Ar­riv­ing on­to the scene, BPG Bio has ac­quired most of the as­sets of an­oth­er biotech.

In an an­nounce­ment, BPG Bio stat­ed that it snapped up all the as­sets of BERG, a Boston-based com­pa­ny that was us­ing AI to map dis­ease and has added BERG’s as­sets to its pipeline. BERG was the name­sake of Carl Berg, an in­vestor and ven­ture cap­i­tal­ist.

BPG­Bio said in its an­nounce­ment that it plans to ac­cel­er­ate the de­vel­op­ment of sev­er­al as­sets that be­longed to BERG but did not give any fi­nan­cial in­for­ma­tion for the ac­qui­si­tion.

Niv­en Narain, the for­mer CEO of BERG, has al­so been ap­point­ed the CEO and pres­i­dent of BPG­bio. The se­nior lead­er­ship from BERG has al­so been brought over to the new biotech as well.

“The in­com­ing com­mer­cial in­fra­struc­ture will fu­el a fo­cus on ad­vanc­ing our lead as­sets with key part­ners across in­dus­try, gov­ern­ment and acad­e­mia,” Narain said in a re­lease sent to End­points News.

BPG has sev­er­al drugs in its pipeline that aim to treat Pan­cre­at­ic Can­cer, Glioblas­toma, and Epi­der­mol­y­sis Bul­losa, among oth­ers. The biotech al­so aims to ex­pand to the west coast and across the At­lantic to the UK.


Ed­i­tors Note: A cor­rec­tion has been made to the spelling of Niv­en Narain’s name.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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89bio to net $275M from stock of­fer­ing; As­sem­bly Bio to pause work on one HBV in­hibitor pro­gram

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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