CNS biotech's stock dives — again — as lead can­di­date fails sec­ond PhI­II test

On Wednes­day, Rel­ma­da Ther­a­peu­tics ran in­to yet an­oth­er ma­jor prob­lem for its lead can­di­date, two months af­ter fac­ing an ear­li­er set­back.

The CNS-fo­cused biotech re­vealed that REL-1017, its lead can­di­date that it has been de­vel­op­ing for ma­jor de­pres­sive dis­or­der, failed to reach the pri­ma­ry end­point in a Phase III study, look­ing at the drug as an ad­junc­tive treat­ment. The end­point was a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in de­pres­sion symp­toms com­pared to place­bo at 28 days, mea­sured by the Mont­gomery-As­berg De­pres­sion Rat­ing Scale.

In the study, the 113 pa­tients in the REL-1017 treat­ment arm saw a re­duc­tion of 15.1 points on the de­pres­sion scale af­ter 28 days, com­pared to 12.9 days for the 114 pa­tients on place­bo.

In­vestors took is­sue with Rel­ma­da $RLMD, send­ing the biotech’s shares spi­ral­ing more than 50% to un­der $2 a share as the mar­ket opened Thurs­day morn­ing. Its stock price has fall­en more than 90% since Sep­tem­ber, wip­ing away hun­dreds of mil­lions of dol­lars in mar­ket share af­ter REL-1017 failed to meet the pri­ma­ry end­point in a Phase III MDD tri­al as a monother­a­py.

That tri­al showed that af­ter 28 days, pa­tients who took the drug saw their scores de­crease by 14.8 points com­pared to 13.9 points from those on place­bo. Rel­ma­da re­port­ed a p-val­ue of p=0.28 at 28 days.

The biotech point­ed the fin­ger again at the same fac­tors that it blamed for a pre­vi­ous tri­al fail­ure, in­clud­ing “a lim­it­ed num­ber of high en­rolling sites with un­plau­si­ble place­bo re­sponse.” Per a state­ment, “im­plau­si­ble re­sults were again ob­served in two of the same high en­rolling RE­LIANCE I (Study 301) study cen­ters, where place­bo dra­mat­i­cal­ly out­per­formed REL-1017.”

Ex­ecs told in­vestors and an­a­lysts on a con­fer­ence call Wednes­day dis­cussing the re­sults that the com­pa­ny will have dis­cus­sions with FDA, in­clud­ing whether a Phase II tri­al, which did show some pos­i­tive ef­fi­ca­cy da­ta, could be con­sid­ered suf­fi­cient as a suc­cess­ful study.

Rel­ma­da’s goal has been to cre­ate a de­pres­sion drug that acts rapid­ly, in con­trast to SS­RIs that could take weeks to start work­ing. The FDA had ap­proved a rapid-act­ing ther­a­py for MDD back in Au­gust, Ax­some’s Au­veli­ty, which is an NM­DA re­cep­tor an­tag­o­nist. REL-1017 is a ND­MA re­cep­tor “chan­nel block­er,” Rel­ma­da says.

Rel­ma­da said that it will con­tin­ue to en­roll pa­tients in RE­LIANCE II, an­oth­er on­go­ing Phase III tri­al look­ing at REL-1017 as a po­ten­tial ad­junc­tive treat­ment for MDD. How­ev­er, it did say that Rel­ma­da will be im­ple­ment­ing some undis­closed pro­to­col and op­er­a­tional changes to the tri­al, and ad­di­tion­al­ly mak­ing “cer­tain im­prove­ments” to how the tri­al is run.

RE­LIANCE II is the biotech’s last Phase III tri­al look­ing at REL-1017 in MDD.

Rel­ma­da de­clined to com­ment to End­points News out­side of a state­ment and the ear­li­er con­fer­ence call.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.