Target to $41 from $34
Thursday, May 20, 2021
Wednesday, May 19, 2021
Noom Gets Silver Lake Backing Ahead of Potential IPO
Noom Inc., an app marketed to aid weight loss by building new habits, received funding from private equity firm Silver Lake ahead of a planned public listing, according to people with knowledge of the matter.
The company reached a value of about $4 billion in the funding round, which also included other investors, according to one of the people.
The company has met with potential advisers to discuss an initial public offering that could happen this year or early next year, said the people, who asked not to be identified because the information was private.
Noom is aiming to be valued at around $10 billion when it goes public depending on market conditions, the people said.
Noom’s plans aren’t final and the details of its IPO, including timing and valuation, could still change, they said.
Representatives for Noom and Silver Lake declined to comment.
Eating Habits
Noom, which combines human coaches and artificial intelligence, markets its app to address the psychological roots of eating habits to help people make better decisions about nutrition.
Last year, the New York-based company announced the appointment of its first chief financial officer, Michael Noonan, who had been head of investor relations at Booking Holdings Inc.
Silver Lake, founded in 1999, is known for its bets on technology companies like computer-maker Dell Technologies Inc. It’s been active in investing in Internet companies as well and last year it put money into Airbnb Inc., Expedia Inc. and Twitter Inc.
Noom wouldn’t be its first deal related to health and fitness. It’s an investor in health-related companies including Verily, Equinox Holdings and GoodRX Holdings Inc., Silver Lake’s website showed.
Noom is backed by investors including Sequoia Capital, Kleiner Perkins, RRE Ventures, Qualcomm Ventures, WhatsApp co-founder Jan Koum and tennis star Serena Williams. The company, founded under a different name over a decade ago, has raised about $129 million to date, according to data provider PitchBook.
Noom was accused in a lawsuit last year of illegally tracking visitors to its website. The claims were dismissed last month by a federal judge in California.
Merus details on Zenocutuzumab in NRG1-fusion (NRG1+) Cancers at ASCO meet
51 patients with NRG1+ cancer have been treated, including 33 patients evaluable for response, as of the January 12, 2021, data cutoff date
- Encouraging early clinical activity observed, with confirmed partial responses in 4 of 10 patients with pancreatic cancer (40%) and in 9 of 33 patients across all NRG1+ tumor types (27%)- Zenocutuzumab observed to be well tolerated with most adverse events being mild or moderate (Grade 1 or 2)
- Oral presentation of an updated interim analysis of 45 evaluable patients to be presented at ASCO on June 4, 11 AM-2 PM ET
- Company to host investor call to discuss clinical results and provide a program update on Sunday, June 6 at 6:00 PM ET
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Sunday, June 6, 2021 at 6:00 pm ET to discuss the Zeno clinical data and provide a program update. A replay will be available after the completion of the call on the Investors and Media section of our website.
Date: Sunday, June 6, 6:00 pm ET
Webcast link: available on our website
Dial-in: Toll-Free: 1-877-260-1463 / International: 1-706-643-5907
Conference ID: 9678617
https://finance.yahoo.com/news/merus-announces-publication-abstract-zenocutuzumab-210100475.html
Bristol Myers Antibody Combo Significantly Improves Progression-Free Survival vs. Opdivo in Melanoma
First presentation of Phase 3 data from a trial evaluating a LAG-3-blocking antibody
Fixed-dose combination of relatlimab and nivolumab demonstrated statistically significant and clinically meaningful benefit over Opdivo monotherapy, an established standard of care
Data demonstrate inhibiting LAG-3 together with PD-1 helps improve outcomes for patients
Data to be featured in an oral presentation during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting
https://www.yahoo.com/now/bristol-myers-squibb-announces-lag-210000199.html
Emergent may be able to resume J&J COVID-19 shot production 'within days'
Emergent BioSolutions Inc could resume making Johnson & Johnson's COVID-19 vaccine "within days" of getting the regulatory go-ahead, but is still fixing the problems that ruined millions of doses in March, its chief executive said on Wednesday at a U.S. House Oversight Committee hearing.
Emergent told the U.S. Food and Drug Administration in recent weeks it may take until July to correct all of the problems at its manufacturing facility, including training staff and acquiring additional refrigerators, according to a private correspondence published by the Oversight Committee on Wednesday.
"As we articulated to the FDA... there are a number of steps that we suggested be implemented," Emergent CEO Robert Kramer said during the hearing. "We are very close to completing them, and I would expect that we will be in a position to resume production within a matter of days."
The FDA halted production of J&J's vaccine at Emergent's Baltimore plant in April after an inspection flagged numerous serious quality control and sanitary issues.
The company contaminated millions of vaccine doses during multiple incidents in 2020 and 2021, the memo said.
Emergent shares were down 3%, while J&J shares were off slightly.
Kramer said it was his understanding that there are 100 million doses of J&J's one-shot vaccine ready for FDA review and that regulators began the review process more than a week ago.
Emergent Executive Chairman Fuad El-Hibri was repeatedly questioned at the hearing about his ties to the Trump administration. An official under former President Donald Trump who oversaw the U.S. government's vaccine deal with Emergent had previously received consulting fees from the company, the U.S. House memo said.
El-Hibri said it was "simply not true" that his relationship with Trump official Robert Kadlec influenced the U.S. government's contract award.
Kramer said at the hearing that he "can't specifically comment" on the total number of COVID-19 vaccine doses that were ruined at the Baltimore facility.
In March he said material for 15 million J&J doses was ruined. He also said "a number" of batches of AstraZeneca's COVID-19 vaccine were ruined in early production ramp ups.
It is unclear whether Emergent can begin manufacturing more COVID-19 vaccine before correcting all the issues flagged by U.S. regulators.
'DESTROYING MILLIONS OF VACCINE DOSES'
Emergent had not previously disclosed a timeline for resuming vaccine production. In a late April investor call, Kramer said he is "hopeful that we can soon return to producing tens of millions of doses per month."
Staff working for the government's Operation Warp Speed program in June 2020 flagged "significant" personnel issues at Emergent's Maryland plant, including that "the staffing plans presented seem inadequate" to produce three products, according to a draft report cited in the memo.
The report said recent audits, including one by the FDA, "highlighted the need for extensive training of personnel."
The memo also said Emergent executives gave themselves millions of dollars in bonuses in 2020 despite knowing that their facilities were ruining batches of COVID-19 vaccines.
J&J's vaccine was contaminated with ingredients from AstraZeneca's shot, which was also being produced at the plant at the time. Production of AstraZeneca's vaccine was subsequently moved elsewhere and manufacture of J&J's vaccine was halted there after the FDA inspection.
"At the same time that the company was destroying millions of vaccine doses... its executives were cashing out," said U.S. Congresswoman Carolyn Maloney, a Democrat.
Kramer said the U.S. government contracted with Emergent in 2012 to help it prepare for public health emergencies, but failed to provide the financial support needed to boost capacity ahead of the pandemic.
U.S. government funding "persistently fell short of what was needed to reach full operating potential," Kramer said in his opening remarks to the Congressional committee.
"As a result, at the end of 2019, (the Baltimore plant) had roughly 100 employees," and was less than a year away from being charged with making millions of COVID-19 shots, the CEO said.
https://news.yahoo.com/1-emergent-plans-fix-issues-154417290.html
Allogene: Positive results from early CAR[T lymphoma candidate
ALLO-501 ALPHA Trial Produced Durable Complete Responses (CR) with Longest Ongoing CR at 15 Months in Both Large B Cell Lymphoma (LBCL) and Follicular Lymphoma (FL)
Overall Response Rate (ORR) of 75% and CR Rate of 50% Across Histologies in CAR T Naïve Patients, on Par with Data from Pivotal Trials of Autologous CAR T Therapies
Six Month CR Rate of 36% with One Time Treatment in CAR T Naïve Patients with LBCL
98% of Enrolled Patients Received ALLO-501 With a Median Time of 5 Days from Enrollment to Start of Therapy
Interim Phase 1 ALPHA2 Data Demonstrated a Comparable Efficacy and Safety Profile for ALLO-501A Relative to ALLO-501
Consolidation Dosing was Well Tolerated and Shows Early Promise with Four Patients Converting from Partial Response (PR) to CR Following Second Dose of ALLO-501 or ALLO-501A
No Dose Limiting Toxicities or Graft-vs-Host Disease; Limited Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Cytokine Release Syndrome (CRS)
Safety and PK/PD Data of ALLO-647 with Flu/Cy Across ALPHA, ALPHA2 and UNIVERSAL (ALLO-715 in Multiple Myeloma) Trials Demonstrated Manageable Safety Profile; Exposure-Dependent Deep Lymphodepletion Correlated with AlloCAR T Cell Expansion and Clinical Responses
Initiation of Pivotal Trial of ALLO-501A Planned for Late 2021
Two Posters to be Presented at the Annual Meeting of the American Society of Clinical Oncology on June 4, 2021 on ALLO-501, ALLO-501A and ALLO-647
Company to Host May 19 Virtual CD19 Forum at 5:30 PM Eastern Time
SOUTH SAN FRANCISCO, Calif., May 19, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer will discuss progress on its AlloCAR T platform during today’s virtual CD19 Forum. The Forum will include results from Phase 1 ALPHA (ALLO-501) and ALPHA2 (ALLO-501A) trials in relapsed/refractory non-Hodgkin lymphoma (NHL), developed in collaboration with Servier, as well as safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from ALLO-647. ALLO-647 is part of the Company’s differentiated lymphodepletion regimen. The Forum will also discuss the Company’s approach for optimizing the unique benefits of its allogeneic CAR T therapy platform and the potential role of AlloCAR T therapy in NHL based upon views from clinical trial investigators and early market research.
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