Herriot Tabuteau, Axsome CEO (Owen Hoffmann/Patrick McMullan via Getty Images)

Ax­some's long de­layed de­pres­sion drug is back up for la­bel dis­cus­sions at the FDA, trig­ger­ing a big spike in the share price

Ax­some’s on-and-off quest to ob­tain an FDA ap­proval for their de­pres­sion drug AXS-05 is back on again.

Af­ter the mar­kets closed on Mon­day, the biotech is­sued a short, sim­ple alert in an SEC fil­ing say­ing the team had “re­ceived from the U.S. Food and Drug Ad­min­is­tra­tion (the “FDA”) pro­posed la­bel­ing for the Com­pa­ny’s AXS-05 prod­uct can­di­date with re­spect to its New Drug Ap­pli­ca­tion (the “NDA”) for AXS-05 for the treat­ment of ma­jor de­pres­sive dis­or­der. The Com­pa­ny is re­view­ing the pro­posed la­bel­ing and will re­ply to the FDA to se­cure fi­nal la­bel­ing agree­ment.”

The fil­ing trig­gered a fren­zy among in­vestors — most of whom have had a steady di­et of bad biotech news to di­gest this year — send­ing Ax­some’s stock $AXSM up 51% af­ter the bell and push­ing its mar­ket cap to the $1.44 bil­lion mark.

That’s a po­lar shift from last sum­mer when Ax­some an­nounced that the la­bel­ing process for their prospec­tive block­buster for ma­jor de­pres­sive dis­or­der had been side­lined af­ter reg­u­la­tors had iden­ti­fied “de­fi­cien­cies” that had halt­ed dis­cus­sions about the la­bel.

There’s no guar­an­tee of suc­cess, of course, but reg­u­la­tors and de­vel­op­ers gen­er­al­ly hash out a drug la­bel in the weeks be­fore an ap­proval. So the long-de­layed drug now has a shot at a near-term suc­cess.

Ax­some got the par­ty for AXS-05 start­ed again back in April when an ear­li­er SEC fil­ing not­ed that they had reached an agree­ment with the FDA on post-mar­ket­ing con­di­tions.

Ax­some’s drug of­fers a com­bi­na­tion of dex­tromethor­phan and bupro­pi­on, some­thing some an­a­lysts ex­cit­ed­ly be­lieve can earn over $1 bil­lion a year. And the biotech has earned break­through ti­tles at the FDA for ma­jor de­pres­sion as well as Alzheimer’s ag­i­ta­tion, where Lund­beck has now been mak­ing progress.

Marc Good­man at SVB Se­cu­ri­ties picked up on the fil­ing in a note, say­ing:

The usu­al process is that the FDA and a com­pa­ny would start la­bel­ing ne­go­ti­a­tions about one month be­fore the PDU­FA date, but giv­en there is no ac­tion date, it’s dif­fi­cult to know the tim­ing in this sit­u­a­tion, but we will as­sume ap­proval in about 1 month. Giv­en the saga with this drug ap­proval process, we be­lieve that many in­vestors are still some­what hes­i­tant on full ap­proval, and thus we wouldn’t be sur­prised to see an­oth­er sig­nif­i­cant jump in the stock on full ap­proval.

Ax­some has al­so been grap­pling with snags around its mi­graine drug AXS-07, which was re­ject­ed a few weeks ago on CMC is­sues.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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