Target $13
Monday, July 8, 2024
Takeda spinout HilleVax sees stock sink 80% as norovirus vaccine flunks phase 2
HilleVax's stock took a nosedive after the vaccine biotech’s sole clinical-stage candidate failed a phase 2b trial in norovirus-related acute gastroenteritis (AGE).
The virus-like particle-based vaccine, dubbed HIL-214, missed all primary and secondary endpoints of the NEST-IN1 study of more than 2,800 infants aged about five months of age in the U.S. and Latin America.
The vaccine showed an efficacy of 5%, with 51 primary endpoints among the 1,425 infants who received HIL-214 and 25 of these endpoints among the 1,399 infants who received placebo.
As a result, the study did not meet the key endpoint of demonstrating efficacy against moderate or severe AGE events caused by the GI.1 or GII.4 norovirus genotypes, HilleVax noted. Even a look at the secondary endpoints was unable to produce any evidence of clinical benefit, according to the company.
The biotech’s stock was trading down 88% to $1.70 in premarket trading Monday from a Friday closing price of $14.06. HilleVax went public in 2022, less than a year after spinning out from Takeda.
Based on today’s results, the company will discontinue testing HIL-214 in infants, and is now “exploring the potential for continued development of HIL-214 and HIL-216 in adults.” In today’s release, HilleVax described HIL-216 as a “phase 1-ready vaccine candidate,” although the company doesn’t mention the vaccine on its pipeline page or in the most recent company update.
“We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint,” CEO Rob Hershberg, M.D., Ph.D., said in the July 8 release.
“While HIL-214 previously showed clinical benefit in adults, NEST-IN1 was the first efficacy study conducted in infants for a norovirus vaccine candidate,” Hershberg added. “We believe the efficacy in the infant setting may have been impacted by the appearance of multiple emerging GII.4 strains in this trial.”
Hopes had been high for HIL-214 after a phase 2b study in adults, NEST-IN1, demonstrated statistically significant efficacy. As recently as the company’s May earnings report, the biotech was outlining to investors how positive results from NEST-IN1 would set the company up to “rapidly progress into phase 3 clinical trials in both infants and older adults.”
Pulse Breakthrough Device Designation for CellFX® nsPFA Cardiac Surgery System for Afib
Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company’s Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF).
Anovis up after Phase III Parkinson’s subgroup success
Annovis Bio has shared delayed data from its Phase III trial showing that its lead candidate buntanetap (previously ANVS401 or Posiphen) improved cognition in patients with Parkinson’s disease.
The Pennsylvania, US-headquartered company shared data focused on a subgroup analysis, touting significant improvements in both MDS-UPDRS Part II, Part III and Phase II+III scores for the 20mg buntanetap dose compared to placebo and baseline in patients diagnosed more than three years ago.
Another subgroup analysis highlighted significant improvements on MDS-UPDRS Part II, Part III, Part II+III, and total scores in patients with postural instability and gait difficulty (PIGD). This subset of patients is associated with faster disease progression.
The company’s share price closed 76% higher than the previous day following the 2 July announcement.
The company had initially selected MDS-UPDRS Part II+III as the primary endpoint, but ultimately focused on Part II only following US Food and Drug Administration (FDA) feedback, as this was "deemed more appropriate for reflecting clinically relevant changes." Consequently, MDS-UPDRS Part III was made a secondary outcome measure. Buntanetap met both of these endpoints in patients who have been diagnosed for more than three years.
This data is long-awaited, with Annovis previously reporting that it would be published in January 2024. In January the biotech said the timeline had been delayed due to “ongoing data cleaning efforts to ensure accuracy and reliability of the study results.”
The trial (NCT05357989) enrolled 523 patients who received either 10mg or 20mg of buntanetap or placebo. Buntanetap inhibits the formation of neurotoxic proteins like amyloid beta, tau, alpha-synuclein, and TDP43. It aims to reverse neurodegeneration in Parkinson’s and Alzheimer’s by improving synaptic transmission and reducing neuroinflammation.
The company shared data from a Phase II/III clinical trial of buntanetap in Alzheimer’s disease (NCT05686044) in April 2024. This 320-patient trial failed to meet a co-primary endpoint, leading to a drop in company’s share price. Additionally, Annovis announced that there had been a patient screening issue, sharing that the initial recruitment for the trial did not include pre-screening for Alzheimer’s biomarkers in the plasma. Annovis plans to move onto a Phase III trial regardless of this data.
In the announcement accompanying the data, Annovis’ CEO Maria Maccecchini said: “These compelling data reinforce our commitment to advancing buntanetap into a longer study, which will allow us not only to verify observed symptomatic improvements but also to explore buntanetap’s disease-modifying properties.”
Myomo Prelim Q2 Revenues and Operating Metrics
Expects record quarterly revenues of $7.2 million to $7.4 million, an increase of 92% to 97% sequentially
Generates record pipeline additions, and authorizations and orders
Myomo, Inc. (NYSE American: MYO) ("Myomo" or the "Company"), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, reports preliminary revenues and operating metrics for the three months ended June 30, 2024.
Revenues for the second quarter of 2024 are expected to be $7.2 million to $7.4 million, the highest quarterly revenues in the Company’s history. This is up 92% to 97% over the first quarter of 2024, and compares with the Company’s previous expectation for second quarter revenues to be at least $5.0 million. Revenue units are expected to be between 155 and 160 in the second quarter of 2024, an increase of 70% to 76% compared with 91 revenue units in the first quarter of 2024. Payments during the second quarter from the Centers for Medicare & Medicaid Services ("CMS") and certain Medicare Advantage plans reflected the fees published by CMS on April 1, 2024.
Pipeline additions, and authorizations and orders during the second quarter are expected to be approximately 550 and 210, respectively, each a record high.
"Payments from CMS were much faster than we had anticipated at the beginning of the quarter," said Paul R. Gudonis, Myomo’s chairman and chief executive officer. "In addition, we expect to substantially meet our hiring objective for the first half of the year, as we exited the second quarter with nearly 150 employees. The added capacity in our clinical, reimbursement and manufacturing operations enabled us to evaluate a record number of patients and add them to our pipeline, generate a record number of authorizations and orders, and manufacture and deliver a record number of MyoPros."
"With an established claims payment history from Medicare Part B beneficiaries, as of July 1, 2024, we began recording revenue for these patients upon product delivery," added David Henry, Myomo’s chief financial officer.
Myomo expects to report full financial results and operating metrics for the three and six months ended June 30, 2024, as well as its expectations for third quarter and full year 2024 financial results, during the second week of August 2024.
https://finance.yahoo.com/news/myomo-reports-preliminary-second-quarter-123000481.html
Lilly Agrees to Buy US Biotech Morphic in $3.2 Billion Deal
Eli Lilly & Co. agreed to buy U.S. gut-drug maker Morphic Holding Inc. for about $3.2 billion, plowing some of the proceeds from obesity blockbuster Zepbound into its experimental pipeline.
Lilly will pay $57 a share in cash for Waltham, Massachusetts-based Morphic, or 79% more than the closing price Friday, the companies said in a statement Monday. Morphic’s board recommends that stockholders tender their shares in the offer.
Immunology is a core area for Lilly, whose Chief Executive Officer Dave Ricks has promised more early-stage deals to acquire new technologies. For Morphic shareholders, the takeover is a turnaround after disappointing data in a clinical trial led to a selloff last September.
Morphic’s shares soared 75% to $55.78, the highest price since September. The company climbed 10% this year prior to the deal being announced. Lilly’s shares rose less than 1%.
Morphic is developing a so-called selective oral small molecule inhibitor for the treatment of inflammatory bowel disease. The US biotech’s most advanced experimental compound is being studied in three mid-stage clinical trials, two in ulcerative colitis and one in Crohn’s disease. Lilly is already active in the area, winning US Food and Drug Administration approval last year for its Omvoh injection for ulcerative colitis.
Pills like the one Morphic is developing could help doctors treat patients with diseases like ulcerative colitis earlier and also potentially allow for combination treatment for people who are sicker, Daniel Skovronsky, Lilly’s chief scientific officer, said in a statement.
https://finance.yahoo.com/news/lilly-agrees-buy-us-biotech-110605998.html
Staff provides Biden instructions 'how to enter and exit a room’ with large print. pics ahead of events
Staffers for President Biden provide him instructions with large print and photos of venue interiors and his planned path of entry ahead of events the 81-year-old commander-in-chief attends, according to a report.
Documents obtained by Axios on Sunday show how staff help guide Biden – including his specific path to a podium – when he appears at functions. The report comes as the Democrat faces relentless questions about whether he is fit for the Oval Office after an awful debate performance last month against presumptive GOP opponent, former President Donald Trump.
“It surprised me that a seasoned political pro like the president would need detailed verbal and visual instructions on how to enter and exit a room,” a person who staffed a Biden event in the past 18 months told the outlet.
“I staffed a simple fundraiser at a private residence, but they treated it like it was a NATO summit with his movements,” the unidentified staffer also said.
The White House sends event staffers a template to follow when getting their own guidance ready for the president as part of what’s known as “advance work,” according to Axios.
One template reportedly shows a large photo of the event space on each page with big text like “View from podium” and “View from audience.” Two pages also gave separate photos with “Walk to the podium” accompanying the pictures.
But a White House spokesperson downplayed the instructions, telling Axios that “high levels of detail and precision are critical to presidential advance work — regardless of who is president — and these are basic approaches that are used by any modern advance team, including the vice president’s office and agencies.”
A spokesperson for Vice President Kamala Harris confirmed the assertion by the Biden official in a statement to the outlet.
“These documents are standard logistical briefing materials and photos for any principal, including the vice president,” the Veep’s spokesperson said.
The revelation comes the same day that multiple senior House Democrats called on Biden to end his reelection bid during a private call with Minority Leader Hakeem Jeffries, per multiple reports.
While a handful of House Democrats have voiced their concerns about moving forward with Biden at the top of the ticket, the octogenarian has remained steadfast that he has no plans to drop out of the race.
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