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.

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.

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.

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.