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Thursday, August 13, 2026

Candel $200m cash balance, advances aglatimagene toward planned BLA filing in Q4 2026

 

Candel Therapeutics posts Q2 2026 EPS -0.52 on $0 revenue, discloses $201.6M cash balance

  • Q2 2026 non-GAAP EPS was -0.52 (-478% YoY) on revenue of $0, missing EPS but beating revenue estimates.
  • Q2 2026 net loss totaled $38.9 million, as disclosed in Candel Therapeutics’ latest SEC filing.
  • Cash balance of $201.6 million supports a projected cash runway extending into the first quarter of 2028.
  • Company advances aglatimagene program toward a planned Biologics License Application filing in the fourth quarter of 2026.

MeiraGTX beats, completes $25M Bota-vec acquisition with up to $400M Oberland funding

 MeiraGTx reports Q2 2026 results with revenue $321.4M (+8609% YoY), beats revenue estimates, and completes $25M Bota-vec acquisition with up to $400M Oberland funding

https://finviz.com/stock?t=MGTX&p=d

Ovid transfers global soticlestat rights for equity, up to $294.5M milestones plus royalties

 

Ovid transfers global soticlestat rights to Perceptive Advisors–backed NewCo for equity, up to $294.5M milestones plus royalties

  • Reported fiscal Q2 2026 non-GAAP EPS -$0.08 (-33% YoY), beating EPS estimates
  • Fiscal Q2 2026 revenue $733,000 (-88% YoY), exceeding revenue estimates
  • Filed Q2 10-Q reporting $15 million net loss and $169.8 million in cash

Omeros beats as YARTEMLEA launch drives EPS $0.15, revenue $28.5M, turns profit, cash flow positive

 

Omeros beats Q2 2026 estimates as YARTEMLEA launch drives EPS $0.15, revenue $28.5M and turns profit, cash flow positive

  • YARTEMLEA net sales $28.5 million, +188% QoQ in first full commercial quarter.
  • Company generated $1.8 million non-GAAP profit and $4.1 million positive operating cash flow.
  • Non-GAAP EPS $0.15, +135% YoY, on Q2 2026 revenue of $28.5M.
  • Adult patients now ~75% of sales, nearing transplant mix, signaling broadening beyond pediatrics.
  • Seventy‑three U.S. transplant centers ordered; 55–60% key centers have P&T approval.
  • CMS granted NTAP up to $287k per inpatient course plus permanent J-code effective July.
  • Capital structure de-risked via $30.5 million 2029 convertible note repurchase (43% outstanding) and 843k shares retired.
  • Gross-to-net 11.5% remains stable; operating expenses expected to rise modestly with launch and R&D.
  • Management reiterated goal to be company-wide cash-flow positive by mid-2027; no revenue guidance given.
  • EMA issued negative opinion on YARTEMLEA; re-examination underway, leaving European approval uncertain.
  • Q&A centered on C5 competitor use, channel stocking, reimbursement, diagnosis rates, and market size.
  • Main concern: Uncertain European approval and still-limited visibility into the ultimate TA-TMA market size.
  • Strong quarter, driven by rapid YARTEMLEA uptake, early profitability, and balance-sheet de-risking.

Abeona misses

 Abeona Therapeutics Inc reports fiscal Q2 2026 results with non-GAAP EPS $-0.35 (-120% YoY) and revenue $11.4M (+2745% YoY), misses EPS and revenue estimates

https://finviz.com/stock?t=ABEO&p=d

MFN affecting Swiss medicines access, says Interpharma

 Pharma groups have held back from submitting around a third of their new medicines for reimbursement in Switzerland, impinging patient access to new therapies.

That is the finding of a survey by Swiss pharma trade body Interpharma, which links the fall directly to the Trump administration's Most Favoured Nation (MFN) pricing policy, which sets the price that drugmakers can set for new medicines in the US at the same level as the lowest offered in 'comparable' countries.

The anonymous poll of Interpharma member companies suggests that Switzerland – which has been named as one of the reference countries for MFN calculations – is already feeling the effects of the new policy, with companies holding off on the launch of drugs in some markets to avoid skewing the MFN price that will apply in the US.

That ties in with an analysis published by EU pharma organisation EFPIA in May, which found that the time between the approval of new medicines in Europe and their availability to patients, which has been rising in recent years, seems to be gathering pace.

Interpharma data from Switzerland between 2021 and 2024 has already pointed to declining access to innovative medicines. Compared to Germany, only about half of new therapies approved during that period are currently available to patients in Switzerland via the Federal Office of Public Health's Specialties List, which covers drugs that are mandatorily covered by compulsory basic health insurance.

Between January 2025 and June 2026, Interpharma members declined to submit seven of a total of 22 new innovative medicines for reimbursement by Swiss health insurers, due to the MFN regime, according to the report. Moreover, in three cases, the new drugs were not even submitted for approval by the Swissmedic regulatory authority.

"As a result, patients in Switzerland do not have access to around a third of all newly developed, innovative medicines through compulsory health insurance, raising the prospect of a two-tiered healthcare system," said Interpharma in a statement on the finding.

"With this, any speculation about the effects of the MFN regime comes to an end: its impact is already measurable and poses a serious threat to equal access to innovative medicines in Switzerland," it added. "As a reference country for the US with comparatively low purchasing-power-adjusted prices for innovative medicines, Switzerland is particularly exposed."

Another analysis published by EFPIA earlier this year, looking at new drug approvals in the previous 18 months, suggested a decline in the number of FDA-approved medicines that are subsequently cleared by the EMA.

https://pharmaphorum.com/news/mfn-affecting-swiss-medicines-access-says-interpharma

'Turkey, Pakistan, Saudi Arabia to set up military mechanisms under defense pact'

 

Turkey, Pakistan and Saudi Arabia will establish political and military mechanisms to coordinate under a joint defense pact signed last week, Turkey's Defense Ministry said on Thursday.

The mechanisms will bring together the three countries' defense and foreign ministers as well as their military chiefs, the ministry said at a weekly briefing in Ankara.

The three countries signed the Mecca Joint Defense Agreement on Aug. 7, which states that an armed attack on one member will be treated as an attack on all three, similar to NATO's collective defense principle.

The ministry said the countries were also planning joint military exercises and would deepen defense industry cooperation, including possible joint production and technology sharing.

The pact brings together three regional powers amid the Iran war, which has seen Iranian missile attacks reach regional countries.

https://www.iranintl.com/en/202608138062