Titan Medical Announces Commencement of Strategic Review

 Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD) (“Titan” or the “Company”), a medical technology company focused on single access robotic-assisted surgery (RAS), today announced that its Board of Directors (or the “Board”), in consultation with its financial and legal advisors, has determined that it is in the best interest of the Company and its stakeholders to undertake a review and evaluation of strategic alternatives that may be available to the Company to unlock shareholder value. As part of the process, the Board will consider a full range of strategic alternatives including corporate sale, merger or other business combination, a sale of all or a portion of the company’s assets, strategic investment or other significant transaction.

As part of the strategic review process, the Company has engaged Raymond James as financial advisor to advise the Company in connection with this broad and comprehensive review and analysis of strategic alternatives.

Cary G. Vance, Titan’s President and CEO, commented, “Our management team is completely aligned with the Board's decision to explore options to maximize shareholder value. We believe it is prudent to undertake a review of our strategic options to determine the best path forward to realize the value of our innovations in single-access robotic-assisted technologies to maximize shareholder value. Our Board and management team remain committed to our strategy of providing patients, surgeons and hospitals with an innovative improved surgical experience."

The Company has not set a timetable for completion of the process and does not intend to provide any updates on developments unless and until the Company executes a definitive agreement with respect thereto, or the Board otherwise determines that an update is appropriate or required.

While the Company intends to evaluate all options fairly to maximize shareholder value, there can be no assurance that the strategic review process will result in any transaction, or if a transaction is undertaken, as to its terms or timing.

https://finance.yahoo.com/news/titan-medical-announces-commencement-strategic-123000058.html

Veru Q4 update

 U.S. FDA reviewing EUA application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS

European Medicines Agency’s (EMA) Emergency Task Force reviewing sabizabulin for emergency use in EU member states

Sabizabulin also under review for potential emergency authorization by MHRA (UK), TGA (Australia), and Health Canada

Veru preparing for U.S. and international commercialization and distribution of sabizabulin, and manufacturing capacity for drug supply in place

Company to host conference call and webcast today at 8:00 a.m. ET

The audio webcast will be accessible under “Investor Kit” in the Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on December 5, 2022 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 passcode 4646397 (international) for one week.

https://finance.yahoo.com/news/veru-reports-fiscal-2022-fourth-113000419.html

Verve Crashes On The FDA's Long List Of Gene-Editing Concerns

 The Food and Drug Administration has a bevy of safety concerns surrounding Verve Therapeutics' (VERV) gene-editing approach to high cholesterol, leading VERV stock to crash Monday.

Last month, the FDA placed Verve's application to begin human testing in the U.S. on hold. Over the weekend, Verve filed a document with the Securities and Exchange Commission explaining why. Part of the FDA's concerns boil down to safety — worries of genetic edits becoming inheritable and unintended effects of changing the gene responsible for high LDL cholesterol.

In addition, the FDA asked for additional data from ongoing human studies in New Zealand and the U.K.

VERV stock crashed 15% near 20.40 in morning trades on today's stock market. Shares of other gene-editing stocks also tumbled. Crispr Therapeutics (CRSP) lost 3.6% and traded near 52.50. Intellia Therapeutics (NTLA) stock skidded 6.6% near 43.10. Editas Medicine (EDIT) dipped 2.3% near 10. Beam Therapeutics (BEAM) fell 5.7% near 44.10.

VERV Stock: Turning Off A Gene

Verve's approach to high cholesterol sounds simple on its face.

The company hopes to use gene editing to turn off the PCSK9 gene. The gene is responsible for regulating proteins involved in blood cholesterol levels. In some people, these proteins lead to high LDL cholesterol. High cholesterol carries of a host of potential complications, including heart attack, stroke and death.

Though Verve is already testing its drug in people in New Zealand and the U.K., U.S. regulators appear more hesitant.

Verve has tested the gene-editing drug in monkeys. Now, the FDA wants additional information as to whether the drug could be more potent in people. The agency is also concerned about the risk of germline editing. Germline editing involves changing DNA in a way those changes could be passed onto children. It has been widely rejected by the scientific community.

It's important to note, there are non-gene editing approaches to high cholesterol. The first treatment is generally statins, which have been on the market for a long time. There are also drugs that inhibit the PCSK9 proteins. Further, Alnylam Pharmaceuticals (ALNY) sells a drug that temporarily silences the same PCSK9 gene.

Questions Surrounding Side Effects

U.S. regulators also asked Verve to provide additional data regarding the potential risk of unintended and unexpected side effects outside the liver. The actual genetic change, in this case, takes place in the liver.

These requests prodded VERV stock to hit its lowest point since July.

Further, the FDA asked Verve to provide it with additional data from ongoing human tests abroad. The agency also wants Verve to run human testing differently in the U.S. It will require more restrictive contraceptive measures in participants and a longer period of time between doses.

"Verve intends to submit a response as expeditiously as possible," the company said in its filing.

The company expects initial data from the Phase 1 study in New Zealand and the U.K. in the second half of 2023.

https://www.investors.com/news/technology/verv-stock-dives-on-fda-list-of-safety-concerns-for-gene-editing-drug/

Nebraska authorities investigate letters allegedly threatening to ‘shoot’ pro-lifers

 Authorities in Omaha, Nebraska, are investigating two threatening letters allegedly tied to radical pro-abortion group Jane’s Revenge that were sent to a Catholic-affiliated center and a local Christian church. 

“If our right to abortion in Bellevue is taken away due to the attempt to pass an abortion ban and its gets passed we will shoot up your Newman Center with our new AR-14 rifles. Sincerely, Jane’s Revenge,” a note found outside the John Paul II Newman Center near the University of Nebraska-Omaha’s Scott Campus allegedly reads. 

Students for Life president Kristan Hawkins posted a photo of the note to Twitter on Saturday, saying “Jane’s Revenge threatens to shoot pro-lifers.” Members of Students for Life were meeting at the Catholic-affiliated center on Saturday “to strategize about how to use @studentsforlife’s Campaign for Abortion Free Cities to shut down the late-term abortion facility in the state,” according to a Twitter thread by Hawkins.

The note was reported to authorities and the University of Nebraska at Omaha Public Safety’s office posted on social media that it was “alerted to a threat of violence against the John Paul II Newman Center” and called on the public to come forward with any tips on the case.

The note ostensibly posted by a member of Jane’s Revenge was addressed to the director of the Newman Center, Rev. Dan Andrews, KETV reported. 

“This obviously causes us great concern,” Andrews said of the note, according to the Star Herald. “Our number one priority is the safety of our students.”

Later that day, another note was found at the Christ Community Church in Omaha. 

“Friends, earlier today, CCC staff found a threatening note taped to an outside door at CCC. The note claims to be from the abortion rights extremist group, Jane’s Revenge, and makes threats against our Lead Minister and the church relating to an abortion policy discussion taking place in the City of Bellevue,” Christ Community Church said in a message to church members on Saturday evening. The message was provided to Fox News Digital early Sunday afternoon. 

“At least one other Omaha church received a similar letter. We take the threats seriously and filed a report with the City of Omaha Police Department, and are cooperating with their ongoing investigation,” the message continued. 

Lt. Neal Bonacci of the Omaha Police Department told the Star Herald that police responded to Christ Community Church at about 5:15 p.m. local time Saturday. That note also threatened violence and cited Jane’s Revenge, according to Bonacci. 

The church is located just over 5 miles from the Newman Center. 

Bonacci said police are working with federal and local authorities to determine if the threats are credible. “​We take any threat of violence serious and will continue to do our due diligence to ensure a thorough investigation,” Bonacci said.

A spokesperson for the Omaha Police Department confirmed to Fox News Digital on Sunday that “we responded to a report of a threatening note left at Christ Community Church, and are currently investigating.”

Christ Community Church said all events will continue as planned despite the threat, and the police department would provide extra patrols at the church.

Fox News Digital reached out to the FBI inquiring if they are also investigating the notes. 

A recent study conducted by the Crime Prevention Research Center found there were 22 times more attacks against pro-life groups since the leak in early May of a draft Supreme Court opinion overturning Roe v. Wade compared to attacks on pro-choice organizations.

A research team at CPRC found there were 135 attacks against pro-life organizations and supporters between May 3 to Sept. 24 of this year compared to six attacks on pro-choice groups and supporters. 

Attacks on pro-life centers exploded soon after the historic leak in early May. In June, Jane’s Revenge even took credit for some attacks and declared it “open season” on pro-lifers.

“From here forward, any anti-choice group who closes their doors, and stops operating will no longer be a target. But until you do, it’s open season, and we know where your operations are,” a letter from Jane’s Revenge dated June 14 reads. 

https://nypost.com/2022/12/04/nebraska-authorities-investigate-letters-allegedly-threatening-to-shoot-pro-lifers/

MaxCyte License to Enable Cell & Gene Therapies for Treatment of Rare Intractable Diseases

 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, and Curamys, a South Korean biotechnology company that develops cell & gene therapy using cell fusion technology to treat rare intractable diseases, including Duchenne muscular dystrophy and amyotrophic lateral sclerosis, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Curamys obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related revenue.

https://finance.yahoo.com/news/maxcyte-signs-strategic-platform-license-070000514.html

GSK cancer division delivers good news after string of R&D setbacks

 GSK has reported much-needed progress with two of its cancer therapies, with a phase 3 trial win for immunotherapy Jemperli in endometrial cancer and the start of a review in the EU for myelofibrosis drug momelotinib.

PD-1 inhibitor Jemperli (dostarlimab) hit the mark in the RUBY trial in primary advanced or recurrent endometrial cancer, becoming the first immunotherapy to show an improvement in progression-free survival (PFS) when used as first-line treatment for these patients, said GSK.

Meanwhile, the EMA has kicked off its regulatory review of momelotinib as a potential new oral treatment for myelofibrosis that can tackle key characteristics of the disorder, including symptoms such as fatigue, fever, and pain as well as anaemia and enlargement of the spleen.

The positive news comes after a challenging time for GSK, marked by the withdrawal of its US marketing approval for multiple myeloma therapy Blenrep (belantamab mafodotin) last month, along with the narrowing of the label for PARP inhibitor Zejula (niraparib), as well as a retreat from the cell therapy category.

Those setbacks in its oncology business followed the abandonment of late-stage trials for rheumatoid arthritis hope otilimab and an advisory committee vote for renal anaemia drug daprodustat that could restrict its commercial potential.

The RUBY trial data gives GSK an opportunity to extend the indications for Jemperli – already approved for patients with recurrent or advanced endometrial cancer with mismatch repair deficient (dMMR) mutations last year – to include a much larger eligible patient population.

The trial tested Jemperli given alongside chemotherapy with carboplatin and paclitaxel, followed by Jemperli alone, to a control group given placebo plus chemo followed by placebo. Both groups included patients with and without dMMR and microsatellite instability-high (MSI-H) mutations, with an improvement in PFS seen in the ‘all-comer’ group, as well as the subgroup with mutations.

GSK plans to file for approval of Jemperli in this setting in the first half of 2023, and if it gets the nod from regulators the drug could claim a category of the endometrial cancer market unaddressed by immuno-oncology rivals like Merck & Co’s Keytruda (pembrolizumab).

Meanwhile, with the EMA now formally starting its review of momelotinib, GSK could be in a position to get approval for the drug in late 2023/early 2024 in the EU, a few months after the FDA is scheduled to deliver its verdict on it in the US next June.

GSK maintains that momelotinib could answer an unmet need in myelofibrosis patients with anaemia, a symptom of the disease that can be made worse by current JAK inhibitor therapies for the disease including Novartis/Incyte’s blockbuster Jakafi (ruxolitinib).

Like Jakafi, momelotinib is a JAK1/2 inhibitor, treating symptoms of the cancer, but also targets other pathways called ACVR1 and IRAK1 that are thought to protect against red blood cell destruction.

Anaemia is the main reason why people with myelofibrosis discontinue treatment, seen in around 40% at diagnosis with almost all patients going on to develop it eventually. As treatment with JAK inhibitors can make anaemia worse, they can raise the risk of complications and blood transfusions.

GSK reckons momelotinib can become a $1 billion-plus product if approved in both the US and Europe.

https://pharmaphorum.com/news/gsk-cancer-division-delivers-good-news-after-string-of-rd-setbacks/

TherapeuticsMD to License its Products to Mayne Pharma

 TXMD to receive approximately $153.1 million in consideration at closing (including approximately $13.1 million for acquired net working capital), up to approximately $42.6 million in minimum royalty payments, and up to $30.0 million in additional milestone payments -

- Mayne Pharma gains exclusive U.S. commercialization rights for TXMD’s products -

- Transaction allows TXMD to recapitalize and transform into a pharmaceutical royalty company -

https://finance.yahoo.com/news/therapeuticsmd-announces-definitive-agreements-license-230000161.html