Usama Malik, ex-Immunomedics CFO

For­mer Im­munomedics staffer pleads guilty in in­sid­er trad­ing scheme af­ter get­ting in­fo from ex-CFO Us­ama Ma­lik

Just over a month ago, Us­ama Ma­lik was in­dict­ed for giv­ing his girl­friend, among oth­ers, in­sid­er in­for­ma­tion that end­ed up with her mak­ing more than $200,000 in prof­it. Now, she has filed a guilty plea.

The plea, signed March 6, was filed yes­ter­day in fed­er­al court be­fore New Jer­sey Dis­trict Judge John Michael Vazquez af­ter Lau­ren Wood, Ma­lik’s ex-girl­friend and a for­mer Im­munomedics em­ploy­ee, agreed to a plea deal.

DOJ had ini­tial­ly al­leged last year that Ma­lik, for­mer­ly the CFO at Im­munomedics, gave in­for­ma­tion to his then-girl­friend and four oth­ers re­gard­ing a Phase III study halt of breast can­cer drug Trodelvy, four days be­fore Im­munomedics pub­licly an­nounced it would be stop­ping the tri­al ear­ly due to promis­ing signs that it helped pa­tients with triple neg­a­tive breast can­cer. Trodelvy lat­er be­came the crown jew­el of the near­ly $21 bil­lion Im­munomedics buy­out by Gilead sev­er­al months af­ter the al­leged in­ci­dent.

The five peo­ple bought a com­bined 9,000 shares in Im­munomedics, hold­ing and then sell­ing af­ter the stock price had al­most dou­bled. Wood, who was no longer at Im­munomedics when the tri­al was halt­ed, had the largest stake, pur­chas­ing close to 7,000 shares and mak­ing over $200,000 in il­le­gal prof­its.

Ac­cord­ing to the plea deal, Wood is plead­ing guilty to se­cu­ri­ties fraud/in­sid­er trad­ing, which can car­ry a max­i­mum prison sen­tence of 20 years and up to a $5 mil­lion fine. Her cur­rent sen­tenc­ing date is Nov. 21. As part of the plea agree­ment, she will waive her right to an ap­peal, for­feit any­thing that was paid for by her il­le­gal prof­its, and pay back her il­le­gal earn­ings.

As for Ma­lik, af­ter he got paid a cool $27 mil­lion in the buy­out, he was al­most im­me­di­ate­ly fired from his last biotech role as CEO at Fore Bio­ther­a­peu­tics once he and Wood were ar­rest­ed back in De­cem­ber. Fore was orig­i­nal­ly named Nov­el­lus­Dx when he joined in Jan­u­ary 2021. He is cur­rent­ly out on bail, and just a few days af­ter be­ing in­dict­ed on three counts of in­sid­er trad­ing, se­cu­ri­ties fraud and se­cu­ri­ties fraud con­spir­a­cy, he filed a not guilty plea last month.

An at­tor­ney af­fil­i­at­ed with Wood did not im­me­di­ate­ly re­spond to a re­quest for com­ment.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.